非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.103072603077103081783078933076403077360.11
211.193082433104803093620.52
单位质量响应值RSD%判断
27723.9627646.290.20数据可信
供试品溶液-6020402批-恩格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154891-5489187.70468.3922.4887.7068.3922.49
246824-4682474.81574.82
333142-3314252.95452.95
450866-5086681.27381.27
531245-3124549.92349.92
639854-3985463.67863.68
10min163948-63948102.17693.739.42103.1594.499.50
261485-6148598.24099.07
359114-5911494.45295.04
463393-63393101.289102.19
550315-5031580.39380.95
653717-5371785.82986.54
15min163555-63555101.54895.185.06103.6696.985.18
260688-6068896.96798.89
361121-6112197.65999.30
459882-5988295.67997.71
555272-5527288.31389.76
656888-5688890.89592.56
20min162240-6224099.44795.784.16102.6898.634.28
261812-6181298.763101.76
361636-6163698.482101.20
459659-5965995.32398.41
555782-5578289.12891.56
658533-5853393.52496.19
30min158358-5835893.24495.731.6097.5999.651.46
260004-6000495.87499.97
360859-6085997.240101.06
460250-6025096.267100.42
559261-5926194.68798.11
660749-6074997.064100.77
45min160651-6065196.90894.711.18102.2999.701.37
259014-5901494.29299.45
359299-5929994.74799.65
458974-5897494.22899.45
558702-5870293.79498.27
659029-5902994.31699.10
60min159802-5980295.55193.801.46102.0199.841.70
258828-5882893.995100.21
359050-5905094.350100.30
459048-5904894.346100.61
557306-5730691.56397.08
658198-5819892.98898.83
90min158250-5825093.07193.130.97100.59100.220.93
258450-5845093.391100.65
359133-5913394.482101.48
457429-5742991.76099.08
557999-5799992.67099.20
658468-5846893.420100.29
120min159127-5912794.47392.831.31103.02100.951.37
257463-5746391.814100.11
358935-5893594.166102.21
457868-5786892.461100.80
557905-5790592.520100.08
657309-5730991.56899.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限158118-5811892.86090.312.15102.4699.462.21
257374-5737491.672100.98
354840-5484087.62396.72
457020-5702091.106100.47
556207-5620789.80798.40
655581-5558188.80797.73
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号250201对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.044053094060354060534059914051504057080.11
2 11.044067804059464063630.15
单位质量响应值RSD%判断
36748.9136808.240.12数据可信
供试品溶液-6020402批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114550-1455017.80212.8333.8417.8012.8333.85
213858-1385816.95616.96
35921-59217.2457.24
412034-1203414.72414.72
57246-72468.8668.87
69319-931911.40211.40
10min134170-3417041.80831.8322.4042.0131.9722.45
230392-3039237.18637.37
320256-2025624.78424.86
427715-2771533.91034.07
519312-1931223.62923.73
624256-2425629.67829.80
15min146643-4664357.07044.4418.3657.7344.9418.43
239991-3999148.93149.53
330457-3045737.26537.62
437502-3750245.88546.43
528260-2826034.57734.94
635095-3509542.94043.40
20min155653-5565368.09454.4817.0469.3955.4717.13
249640-4964060.73661.88
337662-3766246.08146.85
445735-4573555.95957.01
535166-3516643.02743.77
643291-4329152.96853.90
30min164889-6488979.39468.1312.1581.4569.7312.32
259843-5984373.22075.04
347987-4798758.71460.00
457189-5718969.97371.64
547653-4765358.30559.53
656555-5655569.19770.72
45min175583-7558392.47980.4210.5695.4182.7810.74
268650-6865083.99686.63
357002-5700269.74471.68
467859-6785983.02885.48
558445-5844571.51073.38
666841-6684181.78384.07
60min177852-7785295.25587.017.4699.2290.267.74
273605-7360590.05993.63
364858-6485879.35682.07
474049-7404990.60293.97
564714-6471479.18081.85
671589-7158987.59290.79
90min175330-7533092.16993.372.0897.1997.582.21
277825-7782595.22299.79
373673-7367390.14293.73
477609-7760994.95899.34
577112-7711294.35097.90
676313-7631393.37297.54
120min178087-7808795.54395.691.26101.59100.941.21
277965-7796595.393101.02
377997-7799795.432100.02
479149-7914996.842102.28
579407-7940797.158101.75
676660-7666093.79799.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限176412-7641293.49393.821.55100.60100.141.64
278048-7804895.495102.18
375481-7548192.35498.01
477108-7710894.345100.85
577830-7783095.228100.90
675214-7521492.02798.28
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.103078123091313086263090763089593087210.18
211.193115573118063116820.06
单位质量响应值RSD%判断
27812.7027853.620.11数据可信
供试品溶液-1批-恩格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148813-4881377.57886.1310.5977.5886.1210.59
259110-5911093.94393.94
358664-5866493.23493.23
456675-5667590.07390.07
556600-5660089.95489.95
645284-4528471.97071.97
10min159557-5955794.65394.583.6195.5295.543.65
260969-6096996.89897.94
361665-6166598.00499.04
457480-5748091.35392.35
561022-6102296.98297.98
656379-5637989.60390.40
15min160907-6090796.79997.124.0298.7199.133.97
264834-64834103.040105.16
361247-6124797.33999.46
457116-5711690.77492.79
560972-6097296.90298.98
661580-6158097.86999.66
20min160119-6011995.54795.152.6198.5498.242.64
261814-6181498.241101.51
361008-6100896.960100.17
457361-5736191.16394.19
559901-5990195.20098.35
659005-5900593.77696.66
30min160604-6060496.31795.602.18100.3799.752.21
260914-6091496.810101.17
362093-6209398.684102.97
458546-5854693.04797.08
559727-5972794.92499.14
659050-5905093.84897.77
45min159701-5970194.88294.171.12100.0099.371.18
259406-5940694.41399.85
360198-6019895.672101.05
458372-5837292.77097.84
559057-5905793.85999.13
658769-5876993.40198.37
60min160112-6011295.53694.231.77101.71100.481.78
260066-6006695.462101.94
360471-6047196.106102.55
458186-5818692.47598.58
558159-5815992.43298.74
658737-5873793.35099.36
90min158147-5814792.41392.311.5699.6599.611.58
258726-5872693.333100.88
358448-5844892.891100.40
456323-5632389.51496.64
558735-5873593.347100.68
658119-5811992.36899.41
120min157334-5733491.12091.111.9499.3899.441.91
258183-5818392.470101.05
358552-5855293.056101.60
455551-5555188.28796.41
556582-5658289.92598.30
657773-5777391.81899.89
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限157133-5713390.80190.291.30100.0899.631.37
257521-5752191.418101.02
357711-5771191.720101.30
456230-5623089.36698.47
556255-5625589.40698.78
656013-5601389.02198.11
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号250201对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.044067504073384076074077894076154074200.11
2 11.044103574113074108320.17
单位质量响应值RSD%判断
36903.9937213.040.59数据可信
供试品溶液-1批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112015-1201514.59019.8522.7014.5919.8522.70
219196-1919623.31023.31
317487-1748721.23521.23
419170-1917023.27823.28
518964-1896423.02823.03
611264-1126413.67813.68
10min124850-2485030.17632.2317.8930.3432.4517.84
230932-3093237.56137.82
329221-2922135.48435.72
420968-2096825.46225.72
531737-3173738.53938.79
621521-2152126.13326.29
15min138189-3818946.37444.3125.2846.8744.8825.12
249921-4992160.62061.30
337971-3797146.10946.74
424665-2466529.95130.49
540733-4073349.46350.15
627434-2743433.31433.76
20min143213-4321352.47451.4716.7253.4952.5416.74
249006-4900659.50960.86
345442-4544255.18156.32
430673-3067337.24738.12
548447-4844758.83060.06
637551-3755145.59946.41
30min160807-6080773.83966.6015.9575.4368.2415.94
260666-6066673.66875.68
357741-5774170.11671.87
440295-4029548.93150.22
561585-6158574.78476.67
647962-4796258.24159.56
45min168287-6828782.92278.1612.7585.3480.5412.85
271151-7115186.40089.23
365794-6579479.89582.43
450500-5050061.32363.15
571522-7152286.85089.57
658927-5892771.55673.52
60min171133-7113386.37887.332.3989.7290.582.73
275006-7500691.08194.87
372620-7262088.18491.61
470086-7008685.10787.62
571377-7137786.67490.36
671286-7128686.56489.33
90min172465-7246587.99589.304.5392.2993.524.79
276065-7606592.36797.17
374240-7424090.15194.55
467409-6740981.85685.31
576502-7650292.89897.54
674542-7454290.51894.24
120min172810-7281088.41490.733.7593.6995.943.62
275414-7541491.57697.40
375110-7511091.20796.61
471423-7142386.73091.10
573989-7398989.84695.52
679553-7955396.603101.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限173137-7313788.81190.331.3395.0796.551.07
274938-7493890.99897.84
373821-7382189.64296.06
475265-7526591.39696.73
573629-7362989.40996.09
675540-7554091.73097.53
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.103079253087593090113091023083263086250.16
211.193104793096203100500.20
单位质量响应值RSD%判断
27804.0527707.770.25数据可信
供试品溶液-2批-恩格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145681-4568172.80363.3410.8572.8063.3410.85
242706-4270668.06168.06
335754-3575456.98256.98
437035-3703559.02359.02
542049-4204967.01467.01
635242-3524256.16656.17
10min159148-5914894.26594.324.1995.0795.024.21
261045-6104597.28998.04
357862-5786292.21692.85
460350-6035096.18196.84
561705-6170598.34099.09
654970-5497087.60788.23
15min160758-6075896.83197.633.3798.6999.383.40
263825-63825101.719103.56
359252-5925294.43196.09
461030-6103097.26598.99
563611-63611101.378103.22
659071-5907194.14395.74
20min161323-6132397.73297.241.89100.66100.071.94
260862-6086296.99799.96
361419-6141997.885100.59
461232-6123297.587100.39
562348-6234899.365102.33
658888-5888893.85196.49
30min161594-6159498.16497.121.35102.18101.041.45
261274-6127497.654101.70
360187-6018795.92199.72
460970-6097097.169101.06
561859-6185998.586102.65
659749-5974995.22398.91
45min160037-6003795.68296.061.72100.79101.051.78
261598-6159898.170103.30
359163-5916394.28999.15
460113-6011395.803100.77
561416-6141697.880103.04
659299-5929994.50699.25
60min160274-6027496.06095.411.30102.23101.471.34
261213-6121397.556103.78
359811-5981195.322101.23
459402-5940294.670100.70
559433-5943394.720100.97
659065-5906594.13399.93
90min159676-5967695.10794.442.49102.35101.562.47
259176-5917694.310101.61
358261-5826192.85299.82
460208-6020895.955103.04
561203-6120397.540104.84
657024-5702490.88097.72
120min157726-5772691.99992.721.61100.30100.901.64
258665-5866593.496101.85
357382-5738291.45199.45
459161-5916194.286102.44
559142-5914294.256102.64
656997-5699790.83798.69
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限156815-5681590.54791.572.1799.87100.782.13
258569-5856993.343102.73
357015-5701590.86699.88
456310-5631089.74298.94
559425-5942594.707104.14
656616-5661690.23099.09
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号250201对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.044059434068714068764070224063314066090.12
2 11.044089934077214083570.23
单位质量响应值RSD%判断
36830.5336988.860.31数据可信
供试品溶液-2批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115311-1531118.66712.0540.3118.6712.0640.30
26476-64767.8967.90
36599-65998.0458.05
411704-1170414.26914.27
513085-1308515.95315.95
66144-61447.4917.49
10min130202-3020236.82230.8228.5637.0330.9528.58
218092-1809222.05822.15
324700-2470030.11430.20
431449-3144938.34338.50
532002-3200239.01739.19
615228-1522818.56618.65
15min140423-4042349.28445.5223.1549.9046.0023.18
227891-2789134.00534.34
343512-4351253.05053.47
443432-4343252.95253.54
543915-4391553.54154.15
624847-2484730.29330.58
20min145535-4553555.51652.3623.9056.6853.3423.81
230303-3030336.94537.66
355610-5561067.80068.81
451845-5184563.20964.38
542376-4237651.66552.87
631988-3198839.00039.63
30min160141-6014173.32469.0516.0575.1070.6116.20
243842-4384253.45254.57
365626-6562680.01181.78
462960-6296076.76178.64
560622-6062273.91075.69
646621-4662156.84057.90
45min168876-6887683.97382.4511.7086.5784.7811.91
255017-5501767.07768.79
370793-7079386.31188.97
474530-7453090.86793.59
575116-7511691.58194.18
661436-6143674.90376.59
60min174574-7457490.92088.768.3094.4592.018.55
261035-6103574.41476.87
375406-7540691.93595.55
477448-7744894.42498.16
576264-7626492.98196.60
672094-7209487.89790.42
90min177942-7794295.02792.875.7999.5797.106.12
267574-6757482.38685.67
377053-7705393.94398.58
479254-7925496.626101.41
579263-7926396.637101.29
675931-7593192.57596.07
120min176577-7657793.36293.966.9598.9699.226.94
271967-7196787.74291.94
372592-7259288.50494.18
477759-7775994.804100.66
586884-86884105.929111.65
676629-7662993.42697.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限174763-7476391.15190.152.3297.7896.462.65
273763-7376389.93295.11
373244-7324489.29995.96
473446-7344689.54596.46
576780-7678093.610100.51
671673-7167387.38492.95
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.103105433105703100703099583097463101770.12
211.193119373111573115470.18
单位质量响应值RSD%判断
27943.8727841.550.26数据可信
供试品溶液-6020504批-恩格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113565-1356521.51319.6513.6321.5119.6513.62
210358-1035816.42716.43
311719-1171918.58518.59
412335-1233519.56219.56
515053-1505323.87323.87
611300-1130017.92117.92
10min132688-3268851.84042.9323.6552.0843.1523.56
220589-2058932.65232.83
335913-3591356.95557.16
420949-2094933.22333.44
528769-2876945.62545.89
623505-2350537.27737.48
15min144779-4477971.01554.8527.0371.8355.5426.92
224313-2431338.55839.10
345805-4580572.64273.48
426562-2656242.12542.71
537053-3705358.76259.53
629001-2900145.99346.61
20min152267-5226782.89063.0525.2884.4964.3625.21
229037-2903746.05047.02
351385-5138581.49283.14
432167-3216751.01452.07
540268-4026863.86165.29
633418-3341852.99854.12
30min159327-5932794.08776.2721.4896.6178.2821.52
234628-3462854.91756.40
359944-5994495.06597.62
441939-4193966.51168.13
550903-5090380.72782.86
641814-4181466.31368.03
45min163282-63282100.35989.6612.06103.9392.5112.34
246875-4687574.33976.43
363046-6304699.985103.59
455754-5575488.42090.78
559948-5994895.07298.10
650321-5032179.80482.25
60min161024-6102496.77895.645.57101.4699.495.89
253695-5369585.15588.08
362720-6272099.468104.19
461702-6170297.853101.20
562368-6236898.910103.00
660331-6033195.67999.02
90min159678-5967894.64495.901.45100.40100.811.70
259211-5921193.90397.77
360582-6058296.077101.90
461173-6117397.014101.44
561485-6148597.509102.70
660700-6070096.264100.66
120min159488-5948894.34294.841.68101.15100.821.49
259119-5911993.75798.67
358284-5828492.43399.32
460536-6053696.004101.51
560691-6069196.250102.52
660707-6070796.275101.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限159212-5921293.90596.782.43101.77103.822.26
259404-5940494.209100.16
360885-6088596.558104.48
461947-6194798.242104.82
561821-6182198.042105.38
662895-6289599.745106.28
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号250201对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.044087444091554088554087264086524088260.05
2 11.044105634100244102940.10
单位质量响应值RSD%判断
37031.3437164.310.26数据可信
供试品溶液-6020504批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123973-2397329.08026.3011.5429.0826.3011.54
218503-1850322.44422.44
321518-2151826.10226.10
419841-1984124.06724.07
525172-2517230.53430.53
621096-2109625.59025.59
10min155035-5503566.75856.6521.3867.0856.9421.30
237471-3747145.45345.70
361606-6160674.72975.02
435931-3593143.58543.85
545286-4528654.93355.27
644882-4488254.44254.73
15min169313-6931384.07868.8919.8085.1469.8119.75
245987-4598755.78356.54
371621-7162186.87788.00
445669-4566955.39756.15
554056-5405665.57166.52
654115-5411565.64266.53
20min175265-7526591.29776.4516.3593.3078.1416.37
253636-5363665.06166.44
376385-7638592.65694.74
453713-5371365.15566.52
558257-5825770.66672.34
660904-6090473.87775.50
30min179231-7923196.10885.6710.8299.1288.2111.00
262202-6220275.45277.55
380636-8063697.813100.93
464646-6464678.41680.51
567579-6757981.97484.44
669466-6946684.26386.70
45min180258-8025897.35491.934.46101.4495.424.86
272652-7265288.12891.06
379846-7984696.854101.06
473298-7329888.91191.87
574759-7475990.68494.06
673925-7392589.67293.05
60min177982-7798294.59393.991.5099.7698.501.85
277169-7716993.60797.52
379018-7901895.850101.13
477265-7726593.72397.67
575545-7554591.63796.02
677949-7794994.55398.93
90min174824-7482490.76291.403.2796.9896.963.06
279922-7992296.946101.90
376209-7620992.44398.79
473797-7379789.51794.51
573235-7323588.83594.23
674116-7411689.90495.33
120min174642-7464290.54290.262.3297.7696.832.06
277289-7728993.75399.78
373107-7310788.68096.05
473230-7323088.82994.82
572825-7282588.33894.72
675375-7537591.43197.85
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限174994-7499490.96991.461.9699.2099.031.93
277547-7754794.066101.14
376043-7604392.241100.60
474222-7422290.03297.01
573453-7345389.09996.47
676130-7613092.34799.78
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